Effectiveness of a Childcare Intervention on Retention in the Cervical Cancer Screening and Diagnostic Continuum

Information Sheet about participation in a research study titled: Effectiveness of a Childcare Intervention on Retention in the Cervical Cancer Screening and Diagnostic Continuum

To be conducted at Parkland Health Dallas, Texas

Why is this study being done? This study is being done to understand the importance of childcare needs for women using Parkland’s Gynecology Dysplasia Clinic. This study will show us how a childcare facility offered through the hospital affects women’s ability to get care in the Gynecology Dysplasia Clinic.

Who is asked to participate? All women scheduled as a new patient in the Dysplasia Clinic can take part in this study.

Who is conducting the study? Anisha Ganguly, MD, MPH, Health Equity Fellow at Parkland Health and Department of Internal Medicine at UT Southwestern Medical Center, is conducting this study.

Do you have to be in this study? You do not have to take part if you don't want to. You may also leave the study at any time. If you decide to stop taking part in this study, it will not affect your relationship with the UT Southwestern and Parkland staff or doctors. Whether you participate or not will have no effect on your legal rights or the quality of your health care. If you are a medical student, fellow, faculty, or staff at the Medical Center, your status will not be affected in any way.

What are the Research Procedures? Your participation in this study will begin with a telephone call before your first Dysplasia Clinic appointment. You will be asked questions about how childcare impacts your health. The second part of this study is a randomized trial, which means study participants may be in one of two study groups. You will be assigned by chance (like flipping a coin) to one of two study groups: Study Group 1: • Study Group 1 is given assistance enrolling in the childcare facility over the phone. • You will be referred to the childcare resource for your appointment time. Study Group 2: • Study Group 2 is given “standard care”. This means you would have the same resources as anyone coming to any part of Parkland would get, including anyone not taking part in this research study. The first telephone call will take around 15 minutes. If you are in Study Group 2, your telephone call should be less than 15 minutes. Regardless of your study group, about two weeks after your Gynecology Dysplasia Clinic appointment, we will contact you to ask you some follow-up questions about your medical experience and your childcare needs. This call should take around 15 minutes. In addition to the two phone calls, we will also collect medical information from your medical record.

What are the Risks and Benefits? The potential personal benefit of this study may be receiving help with childcare. There may be no other personal benefit to participating in this study. We hope the information learned from this study will benefit other women with similar health and childcare needs in the future. We hope the information we learn will help make childcare available to other clinics and health services. Any time information is collected, there is a possible loss of privacy. Any information that would allow identification of you will be treated as private information. In addition, all information collected will be used only for the purposes of the study. Your information will not be talked about with anyone or given to anyone else without you giving us permission before. Your answers and those of other people taking part in the study will be included in the final report of the study’s results, but we will only report information about the group as a whole. We will not include any of your responses individually where they could be identified as your information.

Payment and Costs: You will not be paid to take part in the study. It will not cost you anything to take part in the study.

Confidentiality: Only the study team will be able to see your answers to our questions and your medical information. Your participation in this study will not affect your medical care during the appointment. All information we learn about you will be kept private. If this study is published anywhere, you won’t be named in any way. Any information we get from this study could be used in another study in the future without telling you about it or getting your permission. However, any information that identifies you will be removed before your information is used. Your permission to use your health information in this study has no expiration date. You may withdraw your permission at any time. If you decide to withdraw your permission, you will no longer be able to take part in this research study. However, the study team may still use and share the information they have from before you withdrew your permission. To withdraw your permission, you can make a request in writing to:

Anisha Ganguly, MD, MPH
Center of Innovation and Value at Parkland
5200 Harry Hines Blvd
Dallas, TX 75235
469-419-9795

Reference Study Number: 2021-0309

The University of Texas Southwestern Medical Center Human Research Protection Program (HRPP) oversees research on human subjects. HRPP and Institutional Review Board (IRB) representatives will answer any questions about your rights as a research subject, and take any concerns, comments or complaints you may wish to offer. You can contact the HRPP by calling the office at 214-648-3060.